BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION

    Reg #: 1834179 · FEI: 1000160371 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Haven Manufacturing
    Registration Number
    1834179
    FEI Number
    1000160371
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    6935 N State Road 1
    City
    OSSIAN
    State
    IN
    ZIP
    46777
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110791

    Owner / Operator

    Firm Name
    CADREX /Haven Manufacturing Indiana
    Operator Number
    9008697
    Address
    6935 N. State Road 1
    City
    Ossian
    State
    IN
    Postal Code
    46777
    Country
    US
    Correspondent
    Leigh Chen

    Products

    Device Name Product Code
    Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented KWT
    Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented HSD

    Proprietary Names

    BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)